MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-24 for XN-10 AP795756 manufactured by Sysmex Corporation, I Square.
[188807736]
The sysmex xn-9000/xn-9100 instructions for use (ifu), chapter 15 - technical information, section 15. 2 - system limitations and interfering substances, informs of situations where results may be affected. For plts, the ifu notes: "if any of the following are present, the system may erroneously report a low platelet count: possibility of plt clumps, pseudothrombocytopenia (caused by edta typically), giant platelets. " large plts were observed during slide review. The ifu further cautions to use good laboratory practices for inspecting specimens for acceptability and verifying results. No product deficiency identified.
Patient Sequence No: 1, Text Type: N, H10
[188807737]
A sample from an obstetrics patient was analyzed and generated a low platelet (plt) result. The plt result was questioned by the physician and a redraw was ordered. Samples were redrawn in both edta anticoagulant and sodium citrate anticoagulant. Both samples were analyzed and generated low plt results. The physician continued to question the plt result. Slide reviews were performed on both samples, and the plt estimates were determined to be within normal range. Several large platelets were present upon slide review and were reported. The physician requested the plt result be evaluated by a pathologist. The pathologist determined the plt count was normal with larger than normal plts. Initially, the user reported the patient experienced a delay in the administration of an epidural based on the low plt result. During follow up conversations, the user was unable to confirm if treatment was delayed or withheld. The delivery proceeded with no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2020-00007 |
| MDR Report Key | 9744620 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NANCY GOULD |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 5439678 |
| Manufacturer G1 | SYSMEX CORPORATION, I SQUARE |
| Manufacturer Street | 262-11 MIZUASHI NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA-CITY, HYOGO 675-0019 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 675-0019 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XN-10 |
| Generic Name | AUTOMATED HEMATOLOGY ANALYZER |
| Product Code | GKZ |
| Date Received | 2020-02-24 |
| Model Number | XN-10 |
| Catalog Number | AP795756 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORPORATION, I SQUARE |
| Manufacturer Address | 262-11 MIZUASHI NOGUCHI-CHO KAKOGAWA-CITY, HYOGO 675-0019 JA 675-0019 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |